Medline Industries, Inc.
TRAY,CATHETER,SUCTION,6 FR,2 Glv,mini
9manufacturers in China registered for this device type
51catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OFR |
| Device type | Tracheobronchial Suction Catheter Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Premarket notification | Exempt |
| Record published | 2022-06-11 |
| Record revised | 2023-06-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 36, case of 6, case of 50, case of 100, case of 20, case of 10 |
| Sizes | Catheter gauge 6 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P6208 | In distribution | |
| DYND40986 | Catheter Gauge 6 Fr | In distribution |
| DYKE1718C | In distribution | |
| DYK1018595S | In distribution | |
| DYNDJ1067A | In distribution | |
| DYNDA2971 | In distribution | |
| DYNJ80496 | In distribution | |
| DYND41442 | In distribution | |
| DYNJT3270 | In distribution | |
| DYNJ59573A | In distribution | |
| DYNJ80281A | In distribution | |
| DYNDA3216 | In distribution | |
| DYND40972 | In distribution | |
| OR516K | In distribution | |
| DYNDA1931B | In distribution | |
| OR527K | In distribution | |
| DYKE1938 | In distribution | |
| DYND41906C | In distribution | |
| DYKM1146 | In distribution | |
| DYNJ14219J | In distribution | |
| P557547 | In distribution | |
| DYKC1145 | In distribution | |
| P809830 | In distribution | |
| DYNDA2992A | In distribution | |
| DYND41470SA | In distribution | |
| DYND41901C | In distribution | |
| DYNDA3034A | In distribution | |
| DYND44705 | In distribution | |
| DYK1006862S | In distribution | |
| DYND41982 | In distribution | |
| DYNDA3014 | In distribution | |
| DYNJ51421D | In distribution | |
| ACC010553 | In distribution | |
| DYKM2723 | In distribution | |
| OR526K | In distribution | |
| DYKM2175 | In distribution | |
| DYNDA1931A | In distribution | |
| DYNDA1138B | In distribution | |
| DYND40982V | In distribution | |
| DYNDA2861A | In distribution | |
| DYK1055623S | In distribution | |
| DYNDJ1145 | In distribution | |
| M101545 | In distribution | |
| DYKM1187 | In distribution | |
| DYND41472 | In distribution | |
| DYNJ39451D | In distribution | |
| DYNDJ1045 | In distribution | |
| DYKE1718F | In distribution | |
| DYKM1559 | In distribution | |
| DYNJ40059D | In distribution | |
| DYNDJ1037 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 16 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 2 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 152 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 413 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-16 | Class II | Under Investigation by firm | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragmen | 14,379 kits total |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-24 | Class II | Under Investigation by firm | A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to par | 141,971 |
| Medline Industries, LP – Northfield | UDI-DI | 2024-06-27 | Class II | Process control | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc | 1,250,374 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 385028 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 1,012,700 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 24192 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.